CAMPRAL EC 333 MG GASTRO-RESISTANT TABLETS

Transcript

S1791 LEAFLET Campral EC 333mg 20160201

PACKAGE LEAFLET: INFORMATION FOR THE USER

Campral® EC 333 mg gastro-resistant tablets
(acamprosate calcium)
Your medicine is known as Campral EC 333 mg gastro-resistant
tablets but will be referred to as Campral tablets throughout the
following leaflet. ‘EC’ stands for ‘Enteric coated’ which is a type of
gastro-resistant tablet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or pharmacist
or nurse.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

Because patients who suffer from alcohol dependence often also
suffer from depression it is recommended that you be monitored for
symptoms of depression.
This medicine is not recommended for children or elderly.
Other medicines and Campral tablets
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Campral has often been given to patients together with other
medicines that are used to treat alcohol withdrawal or maintain
abstinence. So far, Campral does not seem to interfere with the
effects of other medicines, however if you are prescribed diuretics
(water tablets) consult your doctor.
Campral tablets with alcohol
Drinking alcohol while taking Campral does not make you feel
sick, however do not drink alcohol at all during your treatment
with Campral. Even if you drink a small amount of alcohol you run
the risk of making your treatment fail and you may end up drinking
heavily again.

What is in this leaflet
1. What Campral tablets are and what they are used for

Pregnancy and breast-feeding

2. What you need to know before you take Campral tablets

If you are pregnant, think you might be pregnant, or planning to
become pregnant, you should not take Campral tablets without
consulting your doctor first.

3. How to take Campral tablets
4. Possible side effects
5. How to store Campral tablets

If you are breastfeeding, you should not take Campral tablets.

6. Contents of the pack and other information
1. WHAT CAMPRAL TABLETS ARE AND WHAT THEY ARE
USED FOR
Campral is a medicine which acts on the central nervous system
(the brain and the spinal cord). Campral helps people who are
dependent on alcohol to abstain from drinking alcoholic drinks.
Campral in combination with counselling will help you not to drink
alcohol. It does this by acting on the chemical changes that have
taken place in the brain during the years that you have been
drinking alcohol. It does not prevent the harmful effects of
continuous alcohol abuse.

Driving and using machines
Campral does not make you sleepy and therefore is not expected to
affect your ability to drive or use machines.
3. HOW TO TAKE CAMPRAL TABLETS
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose
If you weigh 60 kg or more:

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAMPRAL
TABLETS

The usual dose is 6 tablets a day: 2 tablets in the morning, 2 tablets
at noon and 2 tablets in the evening with meals.
If you weigh less than 60 kg

Do not take Campral tablets:


if you have had an allergic reaction, skin rash, swelling of the
face, wheezing or difficulty breathing after taking acamprosate
(INN) calcium or any of the other ingredients of Campral (see
list of ingredients in section 6) in the past

The usual dose is 4 tablets a day: 2 in the morning, 1 at noon and 1
in the evening with meals.
Duration of treatment:
It is recommended that you keep taking Campral for one year.



if you are pregnant or breast-feeding



if you suffer from severe kidney disease

If you take more Campral tablets than you should



if you suffer from severe liver disease

If you take too many tablets, call your doctor or hospital casualty
department immediately. You may experience diarrhoea and have
raised blood calcium levels.

If you forget to take Campral tablets
Do not take a double dose to make up for a forgotten dose.

You should not be drinking when you start Campral treatment.
Campral will be less effective if you keep drinking.

If you forget to take a dose take it as soon as you remember it and
then take the next dose at the right time.

If you drink too much alcohol, your body system and in particular
your nervous system adapt to the effects of alcohol. When you then
suddenly stop drinking you may experience some unpleasant
symptoms known as alcohol withdrawal syndrome, which can last
up to two weeks.

If you stop taking Campral tablets

You should take Campral tablets as soon as possible after the
withdrawal period.

Talk to your doctor before you stop taking the tablets and follow
their advice.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you experience any of the following side effects with
Campral tablets, STOP taking the tablets and contact your
doctor immediately: A severe allergic reaction, such as angiooedema (causing large raised marks on the skin and localised
swelling, including the face and throat) or anaphylaxis
(causing difficulty in breathing with rash, swelling, wheezing
and feeling faint).
The following side-effects have been reported:
Very common: may affect more than 1 in 10 people


diarrhoea

Common: may affect up to 1 in 10 people

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Campral tablets contain
The active substance is 333 mg acamprosate (INN) calcium.
The other ingredients are: crospovidone, microcrystalline cellulose,
magnesium silicate, sodium starch glycolate, anhydrous colloidal
silica, magnesium stearate, eudragit L30D, talc and propylene
glycol.
What Campral tablets look like and contents of the pack
Campral tablets are white, round, enteric coated tablets marked
with 333 on one side and plain on the other side.
The tablets are available in blister packs of 168 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

allergic reactions including hives, angio-oedema and
anaphylaxis (see the beginning of this section)



blistering rash characterised by patches of skin filled with fluid

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.
5. HOW TO STORE CAMPRAL TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store at room temperature (15-25°C).



Do not take Campral tablets after the expiry date which is stated
on the blister or carton labels. The expiry date refers to the last
day of that month.



Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

Because patients who suffer from alcohol dependence often also
suffer from depression it is recommended that you be monitored for
symptoms of depression.
This medicine is not recommended for children or elderly.
Other medicines and Acamprosate calcium

Your medicine is known as Acamprosate calcium 333 mg gastroresistant tablets but will be referred to as Acamprosate calcium
throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or pharmacist
or nurse.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Acamprosate calcium has often been given to patients together with
other medicines that are used to treat alcohol withdrawal or
maintain abstinence. So far, Acamprosate calcium does not seem
to interfere with the effects of other medicines, however if you are
prescribed diuretics (water tablets) consult your doctor.
Acamprosate calcium with alcohol
Drinking alcohol while taking Acamprosate calcium does not
make you feel sick, however do not drink alcohol at all during
your treatment with Acamprosate calcium. Even if you drink a
small amount of alcohol you run the risk of making your treatment
fail and you may end up drinking heavily again.

1. What Acamprosate calcium are and what they are used for
2. What you need to know before you take Acamprosate calcium

Pregnancy and breast-feeding

3. How to take Acamprosate calcium

If you are pregnant, think you might be pregnant, or planning to
become pregnant, you should not take Acamprosate calcium
without consulting your doctor first.

4. Possible side effects
5. How to store Acamprosate calcium
6. Contents of the pack and other information

If you are breastfeeding, you should not take Acamprosate calcium.

1. WHAT ACAMPROSATE CALCIUM ARE AND WHAT THEY
ARE USED FOR

Driving and using machines
Acamprosate calcium does not make you sleepy and therefore is
not expected to affect your ability to drive or use machines.

Acamprosate calcium is a medicine which acts on the central
nervous system (the brain and the spinal cord). Acamprosate
calcium helps people who are dependent on alcohol to abstain from
drinking alcoholic drinks. Acamprosate calcium in combination with
counselling will help you not to drink alcohol. It does this by acting
on the chemical changes that have taken place in the brain during
the years that you have been drinking alcohol. It does not prevent
the harmful effects of continuous alcohol abuse.

3. HOW TO TAKE ACAMPROSATE CALCIUM
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ACAMPROSATE CALCIUM

If you weigh 60 kg or more:

Do not take Acamprosate calcium:

If you weigh less than 60 kg



The usual dose is 4 tablets a day: 2 in the morning, 1 at noon and 1
in the evening with meals.

if you have had an allergic reaction, skin rash, swelling of the
face, wheezing or difficulty breathing after taking acamprosate
(INN) calcium or any of the other ingredients of Acamprosate
calcium (see list of ingredients in section 6) in the past



if you are pregnant or breast-feeding



if you suffer from severe kidney disease



if you suffer from severe liver disease

The usual dose is 6 tablets a day: 2 tablets in the morning, 2 tablets
at noon and 2 tablets in the evening with meals.

Duration of treatment:
It is recommended that you keep taking Acamprosate calcium for
one year.
If you take more Acamprosate calcium than you should

Warnings and precautions
Tell your doctor or pharmacist before taking Acamprosate calcium.
You should not be drinking when you start Acamprosate
calcium treatment. Acamprosate calcium will be less effective
if you keep drinking.
If you drink too much alcohol, your body system and in particular
your nervous system adapt to the effects of alcohol. When you then
suddenly stop drinking you may experience some unpleasant
symptoms known as alcohol withdrawal syndrome, which can last
up to two weeks.
You should take Acamprosate calcium as soon as possible after the
withdrawal period.

If you take too many tablets, call your doctor or hospital casualty
department immediately. You may experience diarrhoea and have
raised blood calcium levels.
If you forget to take Acamprosate calcium
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose take it as soon as you remember it and
then take the next dose at the right time.
If you stop taking Acamprosate calcium
Talk to your doctor before you stop taking the tablets and follow
their advice.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you experience any of the following side effects with
Acamprosate calcium, STOP taking the tablets and contact
your doctor immediately: A severe allergic reaction, such as
angio-oedema (causing large raised marks on the skin and
localised swelling, including the face and throat) or
anaphylaxis (causing difficulty in breathing with rash, swelling,
wheezing and feeling faint).
The following side-effects have been reported:
Very common: may affect more than 1 in 10 people


diarrhoea

Common: may affect up to 1 in 10 people

What Acamprosate calcium contain
The active substance is 333 mg acamprosate (INN) calcium.
The other ingredients are: crospovidone, microcrystalline cellulose,
magnesium silicate, sodium starch glycolate, anhydrous colloidal
silica, magnesium stearate, eudragit L30D, talc and propylene
glycol.
What Acamprosate calcium look like and contents of the pack
Acamprosate calcium are white, round, enteric coated tablets
marked with 333 on one side and plain on the other side.
The tablets are available in blister packs of 168 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

allergic reactions including hives, angio-oedema and
anaphylaxis (see the beginning of this section)



blistering rash characterised by patches of skin filled with fluid

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of this
medicine.
5. HOW TO STORE ACAMPROSATE CALCIUM


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store at room temperature (15-25°C).



Do not take Acamprosate calcium after the expiry date which is
stated on the blister or carton labels. The expiry date refers to
the last day of that month.



Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.